Glycemic ResponsePROGRESSNCT04881019
PRediction Of Glycemic RESponse Study
An observational study of Glycemic Response, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 1,070 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be composed of 50% individuals with diagnosed T2D (using a validated algorithm) and 50% individuals without a formal diagnosis of T2D and who have a documented HgbA1C < 6.5 within the prior 2 years, matched to the T2D cohort based on age, gender, and BMI.
Who may be able to join
- Age ≥ 18 years.
Who cannot join
- Type 1 diabetes mellitus
- Unable to participate in or comply with any of the testing modules asked during the study
- Currently pregnant
- Prior bariatric surgery
- Chemotherapy or radiation treatment for cancer in the past year
- Inflammatory bowel disease
Show all 12Show fewer
- Known skin allergy to adhesives and nickel (or other contraindications to continuous glucose monitoring)
- Currently taking any oral steroids(these medications may impact glucose levels)
- Antibiotic use in the last 3 months prior to the start of the study or planned use during the duration of the study
- Non-dietary, supplemental probiotic use either daily or weekly
- Hospice care
- End stage renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Research Translational Institute
San Diego, California, 92037
About this study
Official title: Prediction of Glycemic Response Study (PROGRESS)
The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.
Read the detailed description
Interested individuals will be directed to download the MyDataHelps™ (CareEvolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. Participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study.
Once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. This biosamples kit will include:
- Salivary kit for genomics analysis
- Gut microbiome kit
- Home micro-puncture single-use blood collection
Additional study materials and devices include:
- A wrist-worn activity, heart rate and sleep monitor.
- A Dexcom 6 continuous glucose monitor (CGM) and application kit
- A standardized snack bar meal (2 per fasting days)
Participants will be asked to track various digital health measures including their continuous glucose as well as record their meals for a 10-day period. The data connections approved by the participants will continue in the following years.
- Conditions
- Glycemic Response
- Being tested
- Continuous glucose monitoring
- Keywords
- Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Also called Dexcom G6
Continuous monitoring of blood sugar over a 10-day period.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Individuals who have been diagnosed with Type 2 diabetes. Receives: Device: Continuous glucose monitoring | |
| Non type 2 diabetes | Individuals who have not been diagnosed with Type 2 diabetes. Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gylcemic response profiles
Distinguish differences in individual glycemic response characteristics as measured by the continuous glucose monitor (mg/dl) and macronutrients (carbohydrates, fats, and proteins) in participants with (n = 500) and without type 2 diabetes (n = 500) matched for age, sex, BMI.
Measured: 10-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start8 Jun 2021
- Primary completion1 Sep 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CareEvolution Healthcare Technology, Tempus AI
- Responsible party
- Principal investigator, Ed Ramos, Scripps Translational Science Institute
- Investigators
- Edward Ramos, PhD, Principal investigator, Scripps Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881019
- Sponsor's protocol ID
- IRB-20-7635
- Acronym
- PROGRESS
- Status last verified
- Dec 2024
- First submitted
- 6 May 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Glycemic Response Study (PROGRESS)
- ClinicalTrials.gov ID
- NCT04881019
- Acronym / sponsor ID
- PROGRESS / IRB-20-7635
- Conditions
- Glycemic Response
- Keywords
- Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- CareEvolution Healthcare Technology, Tempus AI
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.
Detailed description
Interested individuals will be directed to download the MyDataHelps™ (CareEvolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. Participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study.
Once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. This biosamples kit will include:
- Salivary kit for genomics analysis
- Gut microbiome kit
- Home micro-puncture single-use blood collection
Additional study materials and devices include:
- A wrist-worn activity, heart rate and sleep monitor.
- A Dexcom 6 continuous glucose monitor (CGM) and application kit
- A standardized snack bar meal (2 per fasting days)
Participants will be asked to track various digital health measures including their continuous glucose as well as record their meals for a 10-day period. The data connections approved by the participants will continue in the following years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Device: Continuous glucose monitoringIndividuals who have been diagnosed with Type 2 diabetes. |
| Non type 2 diabetes | – | Device: Continuous glucose monitoringIndividuals who have not been diagnosed with Type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be composed of 50% individuals with diagnosed T2D (using a validated algorithm) and 50% individuals without a formal diagnosis of T2D and who have a documented HgbA1C < 6.5 within the prior 2 years, matched to the T2D cohort based on age, gender, and BMI.
Key inclusion criteria (1 listed)
- Age ≥ 18 years.
Key exclusion criteria (12 listed)
- Type 1 diabetes mellitus
- Unable to participate in or comply with any of the testing modules asked during the study
- Currently pregnant
- Prior bariatric surgery
- Chemotherapy or radiation treatment for cancer in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringAlso: Dexcom G6Continuous monitoring of blood sugar over a 10-day period. | Device | Non type 2 diabetes, Type 2 Diabetes |
Primary outcome
Gylcemic response profiles
Time frame: 10-days
Distinguish differences in individual glycemic response characteristics as measured by the continuous glucose monitor (mg/dl) and macronutrients (carbohydrates, fats, and proteins) in participants with (n = 500) and without type 2 diabetes (n = 500) matched for age, sex, BMI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Ramos, PhD principal investigator
Scripps Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycemic Response, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gylcemic response profiles (time frame: 10-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.